Gemini NOVA 810+980 Soft Tissue Laser

The Gemini Nova 810+980 Soft Tissue Laser is a dual-wavelength diode laser system delivering 810 nm and 980 nm laser energy for oral soft-tissue surgical procedures, including incision, excision, vaporization, ablation, and coagulation. It is used for dental procedures such as gingival surgery, periodontal treatments, biopsy, lesion removal, and pain therapy through topical heating.

The Gemini Nova has the same laser type (GaAlAs diode), wavelengths (810±10 nm, 980±10 nm), and average power range (0.1–2.0 W) as the predicate Gemini 2, but features a lower peak power (20 W vs. 150 W), cordless wireless design with internal lithium-ion batteries, capacitive touchscreen interface, and Bluetooth Low Energy connectivity. Reprocessing uses intermediate-level disinfection for most components rather than full steam sterilization.

Testing was conducted per IEC 60601-1 (electrical safety), IEC 60601-1-2:2014+A1:2020 (EMC), IEC 60601-2-22 (medical laser equipment), IEC 60825-1 (laser product safety), IEC 62304 (software lifecycle), IEC 62133-2:2017 (battery safety), ISO 10993 (biocompatibility including cytotoxicity, sensitization, and irritation), FCC Part 15 Subpart B (RF emissions), and ETSI EN 301 489 standards (wireless coexistence).

Substantial equivalence is based on identical intended use and similar technological characteristics, including the same wavelengths, average power range, and energy delivery methods (fiber tips and PBM adapters). All technological differences—lower peak power, cordless design, touchscreen interface, connectivity, battery power, and reprocessing method—do not raise new safety or effectiveness questions because they do not affect laser energy delivery or clinical performance. Comprehensive non-clinical and bench testing confirmed equivalent performance and safety.